VAXIOM FAMILY OF RF LESION PROBES & ELEC— 510(k) K802243

Name: FDA 510(k) clearance K802243
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Progress Mankind Technology

FDA 510(k) clearance K802243 for VAXIOM FAMILY OF RF LESION PROBES & ELEC, Substantially Equivalent on 1980-11-12. Applicant: Progress Mankind Technology. Device class: 2.

Clearance details

Applicant: Progress Mankind Technology
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 1980-09-16
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXI

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K251802 — STAR RF Ablation System2026-02-13
K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

More clearances from Progress Mankind Technology

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K883314 — PMT 3721-1 EPIDURAL KIT1988-10-28
K881616 — PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-11988-09-09
K871663 — PMT TRACTION TONGS1987-06-19
K854157 — PMT ACCUPRESSURE INFUSION SYSTEM 36011986-02-13
K845035 — ELECTRODE FOR NEUROLOGICAL SURGERY 21111985-07-30

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.